Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07195448

Global Research on Appearance in Cancer (GRACE)

The GRACE Study - Global Research on Appearance in Cancer

Status
Recruiting
Phase
Study type
Observational
Enrollment
800 (estimated)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Gaining insight into how weight loss is perceived by persons with advanced cancer, and identifying potential differences related to gender and country of residence, is essential for developing comprehensive, equitable, gender-sensitive recommendations for medical nutrition therapy, with the aim of improving disease outcome.

Detailed description

This is a multi-country cross-sectional study. Fifty men and 50 women, 18 years and above, diagnosed with advanced cancer, with a life expectancy of \> 3 months, from eight countries (Australia, Chile, Germany, New Zealand, Sweden, Switzerland, USA, Vietnam) will be invited to participate. Study participants will be recruited at cancer clinics, where they will receive a QR code providing access a digital questionnaire one time. No personal information, such as name, address, or social security number, is collected. Therefore, the digital questionnaire is anonymous. Data will be collected on various variables, including weight (in kilograms or pounds) and weight history (weight before diagnosis), height (in centimeters or inches), previous weight loss attempts, education (completed high school/completed college), marital status, body image (Body Image Scale, nutrition impact symptoms (Edmonton Symptom Assessment Scale) and dietary habits (questions about choice of foods in the past week). Regarding missing data, Body Image Scale (BIS), missing items will be handled strictly according to the scoring protocol. No imputation will be applied to other variables, which will be analyzed using complete cases. The proposed sample size is considered appropriate and sufficient to generate valuable insights for the research community in the field of palliative care. While the sample size is not derived from a formal power calculation, the inclusion of 50 men and 50 women from each study site is anticipated to provide robust and meaningful data to address the study objectives effectively.The data will be processed at Karolinska Institutet, Stockholm, Sweden. The statistical analysis to address the objectives is ANCOVA, which will be applied to assess group differences while controlling for covariates.

Conditions

Timeline

Start date
2025-02-10
Primary completion
2026-04-01
Completion
2026-12-01
First posted
2025-09-26
Last updated
2025-10-01

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT07195448. Inclusion in this directory is not an endorsement.